Rigid Protocols for Flexible Endoscope Reprocessing

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Standardization is the only way to ensure instructions for cleaning and high-level disinfecting are followed to the letter.


There are between 75 and 100 intricate steps involved in the proper reprocessing of flexible endoscopes. That means there are countless opportunities for staff to miss critical steps that prevent cross contamination, infection and, in the worst of cases, a patient’s entirely avoidable death. “In 99% of the cases when patients are exposed to pathogens because biofilm is on the scopes, it’s because there was a missed step during reprocessing,” says Albert R. Knight, MAJ, AN, DNP, APRN, AGCNS-BC, CMSRN, CNOR, a perioperative clinical nurse specialist stationed with the U.S. Army at the Landstuhl Regional Medical Center (LRMC) in Germany. “And it’s all because there’s still not a standardized process across the board.”

Dr. Knight has dedicated a significant amount of time and effort to raising awareness about the importance of standardization in flexible endoscope reprocessing. In fact, he’s pushing for a “standard of practice” — much like the WHO’s Surgical Safety Checklist — that reprocessing personnel can use at the local, national and even global level. 

In the meantime, you should rely on industry guidelines, instructions for use (IFU) from the makers of endoscopes and reprocessing equipment and robust internal policies to prevent variations in endoscope reprocessing and ensure that these complex instruments are cleaned the exact same way every time they’re used. Here are the major areas to include in the policies.

Meticulous cleaning. Proper endoscope reprocessing starts at the bedside with thorough point-of-use cleaning where staff flush out the channels and wipe down and remove bioburden from the exterior areas of the scopes. You’d think the very first step in the reprocessing journey would get the attention it deserves, but often that simply isn’t the case — particularly at busy, time-strapped facilities.

You can prevent a lot of errors simply by making sure staff religiously follow the endoscope manufacturer’s IFU — and reminding them about those IFUs as often as possible. “Meticulous bedside cleaning that follows the manufacturer’s IFU is of the utmost importance during the point-of-use phase of reprocessing,” says Marisa C. Ynchausti, BSN, RN, clinical nurse manager at National Ambulatory Surgery Center in Los Gatos, Calif. When staff are under pressure to meet strict turnover time goals, precleaning generally tends to get short shrift, she says.

Once the scopes are cleaned at the bedside, they need to be quickly but safely transported to the reprocessing area to prevent residual bioburden that wasn’t removed during precleaning from hardening and causing a problem in the next phase of care. You can prevent residual materials from hardening and keep the scopes moist during transport by spraying them down with approved foams and sprays.

“The best practice during transportation is to use rigid, secured containers that are dedicated to housing clean or dirty scopes and properly labeled,” says Ms. Ynchausti. In terms of labeling the containers, spell out the exact times of scope removal and transport.

Following a leak test tto ensure the endoscope isn’t damaged, reprocessing techs must thoroughly flush the channels of the scope according to the IFU and brush the channels to the point of friction. This manual cleaning stage of reprocessing is the most important step in the entire process — as the benefits of removing bioburden prior to high-level disinfection can’t be overstated.

“Mechanically removing debris early on in the cleaning process helps to prevent potentially infectious blood, feces or pus from forming and adhering to hard-to-reach interiors of the endoscope,” says Ms. Ynchausti.

DIRTY JOB Proper manual cleaning removes the potentially infectious materials that remain in hard-to-reach areas of endoscope channels.

Proper storage. After scopes are removed from the automated endoscope reprocessor (AER), thoroughly rinsed and dried, they must be stored in drying cabinets with circulating forced air to prevent contamination and protect the devices themselves. “There are commercially available endoscope drying cabinets or cabinets with HEPA filters that circulate air around the scopes,” says Ms. Ynchausti. “Then, tags are attached that show information about the date and time the scope was last reprocessed and by whom to make it easy for the next user to determine whether a particular endoscope is ready for use or whether it needs to be reprocessed again.”

Specialized training. Precleaning at the bedside and manual cleaning in the reprocessing area are the two areas where you see the most mistakes, according to Dr. Knight. “Manual cleaning is a major area where mistakes come into play because there’s often a variance in the critical steps reprocessing technicians take,” he says. “Staff with little experience also see how something is done once and then have to jump in and do it themselves.”

To remedy this problem, he recommends a thorough onboarding of reprocessing technicians as well as requiring the techs to get their Certified Endoscope Reprocessor (CER) certification. “These certifications guarantee that a lot of time and effort goes into learning the process and understanding the ‘why’ behind the various steps of endoscope care,” says Dr. Knight. He says you can avoid problematic variations in technique simply by requiring staff to follow the scope manufacturer’s IFU and providing periodic education to make sure every team member is doing it the right way.

Ms. Ynchausti recommends leaning on a variety of experts to help in this area. “Endoscope service representatives who are up to date on the latest compliance protocols and guidelines will generally provide free or low-cost in-service training on their IFU,” she says. Another option, according to Ms. Ynchausti, is reaching out to regulatory surveyors. “They want to help facilities uphold safety and quality standards and can point you in the right direction with respect to endoscope reprocessing,” she says.

Dr. Knight agrees with the benefits of reaching out to surveyors. “Conduct a mock survey and have surveyors take a hard look at your processes,” he says. “Their feedback might be tough to hear, but ultimately you’re going to come away with a corrective action plan to address your variations — and change your culture.”

Spot checks. Of course, even with properly trained and certified technicians on staff, you still need to regularly audit your processes and monitor technicians closely to ensure that variations or personal preferences don’t seep into the workflow. To that end, Ms. Ynchausti recommends using an easy-to-follow checklist to guide your spot checks and random audits. “My center uses the HICPAC Sample Audit Tool for Flexible Endoscope Reprocessing, which is available for free on the CDC’s website,” she says. (Access the tool here: osmag.net/auditIC.)

Even with the most methodical, uniform manual cleaning processes in place, you’ll still need to verify that scopes are clean — and that’s where rapid adenosine triphosphate protein (ATP) testing, which uncovers whether live bacteria is still present, can pay dividends. “ATP testing is a best practice that should be employed by facilities to ensure scopes have been properly cleaned,” says Dr. Knight. “If a scope doesn’t pass, you reclean and retest it before moving on to the next step in the process.”

The same way, every time

Until we have a standardized universal checklist for endoscope reprocessing like the one that Dr. Knight envisions, it’s up to facility leaders to use the most thorough guidelines available — and the manufacturers’ IFU — to reduce the variation and make endoscope reprocessing as standardized and safe as possible for patients. “It must follow a clearly established, pre-defined and time-tested system that guarantees safety and quality,” says Ms. Ynchausti. “Compliance with standardized processes offers a host of benefits. It minimizes guesswork and shortcuts, eliminates the waste of time and resources, and bolsters staff’s confidence, morale and pride in their own mastery of quality work.” OSM

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